Vascular wound closure system

ABSTRACT

A system which facilitates the closure of puncture wounds in the vasculature of a patient by helping locate and isolate the site of the puncture wound in the patient. A tube or catheter having an indicator hole for aspirating blood assists in locating the exact site of the wound. A retractor moves the surrounding tissue laterally forming an access path to the wound, and acts as a guide for the wound closure device. The retractor and accessories are preferably used in combination with a surgical clip applicator which delivers clips to the site of the wound, but can also be used with other methods of wound closure such as suturing and stapling.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.08/943,369, filed Oct. 3, 1997, now abandoned, which is acontinuation-in-part of U.S. application Ser. No. 08/764,611, filed Dec.5, 1996, now U.S. Pat. No. 6,004,341, which claims the benefit of U.S.Provisional Application Ser. No. 60/009,643 filed Dec. 7, 1995.

FIELD OF THE INVENTION

The present invention relates to a system which assists in the closureof puncture or other wounds in the vasculature of a patient.Specifically, the invention relates to devices which aid in locating andisolating the wound in the vasculature and guiding an appropriate woundclosure device to the site, so that the wound may be closed usingsurgical clips, sutures, or staples.

BACKGROUND OF THE INVENTION

Transluminal balloon angioplasty is used in the treatment of peripheralvascular disease to increase or restore blood flow through asignificantly narrowed artery in a limb; it is also used in thetreatment of blockage of the coronary arteries. In fact, coronaryangioplasty has emerged as a major viable alternative to bypass surgeryfor revascularization of stenotic and occluded coronary arteries. Unlikebypass surgery, angioplasty does not require general anesthesia, openingof the chest wall, use of a heart-lung machine, or transfusion of blood.Angioplasty is not only less invasive and less traumatic to the patient,it is also less expensive because of the shorter hospital stay andshorter recovery time.

Transluminal balloon angioplasty is performed by first inserting ahollow needle through the skin and into the patient's femoral artery. Aguidewire is advanced through the hollow needle and into the artery,then along the patient's vasculature toward the site of the blockedblood vessel or heart valve to be treated. X-ray imaging is used to helpmove the guidewire through the vascular system and into position justpast the stenosis to be treated. A balloon catheter is then threadedover the guidewire and advanced until the deflated balloon is within thestenosis. The balloon is then repeatedly inflated to widen the narrowedblood vessel. After the procedure is complete, the catheter andguidewire are withdrawn from the blood vessels and the patient.

Angiography, which is used to detect diseases that alter the appearanceof blood vessels, is performed in a similar manner. A hollow needle isfirst inserted through the skin and into the femoral artery, and aguidewire is then inserted through the needle and into the affectedblood vessel. A catheter is then threaded over the guidewire and intothe blood vessel to be examined, using x-ray imaging to guide thecatheter to the desired position. Contrast medium is then injected, anda rapid sequence of x-ray pictures are taken so that blood flow alongthe affected vessel can be studied. Once complete, the catheter andguidewire are removed from the patient's body.

After the catheter and guidewire used during angioplasty or angiographyare removed, the puncture wound in the femoral artery must be closed andthe bleeding through the puncture site in the artery stopped. Currently,ice packs and/or pressure are applied to the artery for a period lastingup to several hours in an attempt to stop the bleeding. There exists,however, a significant chance that upon movement by the patient, thewound will reopen and begin bleeding again. Although efforts have beenmade to close the puncture wound using staples, clips, and sutures, theyhave been unsuccessful, largely due to the inability to clearly locateand visualize the puncture wound in the femoral artery.

Other wounds in the vasculature of a patient can also be difficult tolocate and access. Thus, a device and method to facilitate the closurewounds in the vasculature of a patient, such as femoral artery puncturewounds following transluminal balloon angioplasty and angiography, wouldbe extremely beneficial. A device having the ability to aid in locatingthe puncture wound and facilitating the closure of the wound usingstaples, clips, or sutures would eliminate the prolonged bleedingcurrently associated with such wounds.

SUMMARY OF THE INVENTION

The wound closure system of the present invention aids in locating andisolating a puncture wound in the vasculature of a patient. The systemcan be used in conjunction with a guidewire which is normally insertedinto the vasculature during diagnostic and therapeutic procedures. Thedevices of the present invention aid the physician in closing the wound,thus eliminating prolonged bleeding associated with these procedures.

In accordance with one aspect of the present invention, there isprovided a device to facilitate the closure of wounds in the femoralartery. This retractor comprises a body portion separable into twohalves, each of the halves having a flat internal surface with a groove,such that when the internal surfaces abut one another, the grooves forma channel through the entire length of the body portion. The retractorhas a collar portion at one end, having at least one guide passage whichtraverses both halves of the body portion, and at least one pin which isinsertable into the guide passage. A handle extends laterally from thepin to allow the user to easily manipulate the device. At least one setscrew hole can be provided in the collar portion at a right angle to theguide passage, and at least one set screw inserted into the set screwhole to secure the device to the pins.

The device can be made of a biocompatible engineering polymer, such aspolypropylene, polyethylene, or polyterephthalate. Alternatively, anelastomer or a metal can be used to make the device.

A hollow dilator adapted to receive a guidewire is preferably used inconjunction with the retractor. The dilator is inserted through thechannel in the body portion of the retractor, and extends past thedistal end of the reactor. The dilator preferably includes at least oneindicator hole located at the distal end, which extends past the end ofthe retractor. The dilator has a double-sleeved inflatable balloonmounted on its distal end just proximal to the indicator hole, and asecond inflatable balloon mounted just distal to the indicator hole.These balloons help anchor the dilator in place, and provide access tothe puncture wound from the surface of the patient's body. A guidewireis used to help guide the insertion of the dilator. The guidewire isinserted through the hollow dilator, and the dilator advanced over theguidewire into its proper position.

Another aspect of the present invention includes a system forfacilitating the closure of wounds in the vasculature of a patient. Thesystem includes a retractor as described above, a hollow dilator adaptedto receive a guidewire, and a guidewire. The guidewire is insertedthrough the dilator, and the dilator is inserted through the channel inthe retractor. Preferably, a guide assembly adapted to be reversiblyattached to a surgical clip applicator is used. The guide assemblyreceives the guidewire to help guide the clip applicator to the site ofthe puncture wound.

The dilator preferably has a source of negative pressure connected toits proximal end in fluid communication with the hollow dilator. Thesource of negative pressure can be a syringe or any other appropriatesource.

A method for facilitating the closure of a wound in the vasculature of apatient is also described. A guidewire is first inserted into thepatient's vasculature through the wound, until the distal end of theguidewire is within the vasculature and the proximal end remains outsidethe patient's body. The proximal end of the guidewire is inserted intothe distal end of a hollow dilator having a double-sleeved balloon and asecond balloon distal the double-sleeved balloon mounted on it. Thedilator is advanced over the guidewire until it reaches the wound. Theballoons are inflated to anchor the dilator in position, and theproximal end of the dilator is inserted into the distal end of aretractor. The retractor is advanced between the two sleeves of thedouble-sleeved balloon. The two halves of the retractor are separatedand the dilator and the inner sleeve of the double-sleeved balloon areremoved from the patient. Using the retractor and the outer sleeve ofthe balloon as a guide, the wound is accessed and closed by means suchas clipping, stapling, or suturing.

Preferably, a source of negative pressure is provided on the proximalend of the dilator during insertion, until blood is drawn into thedilator from the vasculature. This assists the user in determining whenthe dilator is properly positioned.

A hollow indicator tube mounted on a surgical clip applicator ispreferably used to close the wound. The applicator is advanced over theguidewire and through the channel in the retractor until the applicatorcontacts the wound. To aid proper insertion, a source of negativepressure is provided at the proximal end of the indicator tube, untilblood is drawn into the indicator tube from the vasculature.

In yet another embodiment of the retractor used to facilitate woundclosure, the retractor has a body portion and a handle portion. At itsdistal end, the body portion has a retracting portion having two movablehalves which extend away from the body portion. The halves are formedsuch that when the internal surfaces abut one another, a channel isformed which extends completely through the retracting portion. Thehandle portion connects to the body portion and controls the movement ofthe two moveable halves. Preferably, the handle portion comprises twohandles, and a loop extending from one handle to the other. This loopsurrounds a screw mounted on the other handle. This locking mechanismacts to secure the position of the handles and the retracting portion ofthe retractor.

A hollow catheter having an open proximal end and an open distal end,adapted to receive a guidewire therethrough, is used in conjunction withthe retractor. The hollow catheter is inserted through the channel inthe retracting portion of the retractor. The catheter is preferably adual-lumen catheter, having an inner lumen adapted to receive aguidewire, and an outer lumen which surrounds the inner lumen. The outerlumen has at least one indicator hole located in an outer wall to allowfor the aspiration of blood through the outer lumen. This helps positionthe catheter properly within the patient's body.

The retractor and dual-lumen catheter are used in the following manner.The retractor is mounted on the outside of the distal end of thecatheter, approximately 0.5 mm behind the indicator hole located in theoutside wall of the catheter. The proximal end of a guidewire which isalready in place in the patient as a result of a diagnostic ortherapeutic procedure, is inserted into the distal end of the innerlumen of the dual-lumen catheter, and the catheter and retractor areadvanced as a single unit over the guidewire.

Preferably, a source of negative pressure is provided at the proximalend of the outer lumen of the dual-lumen catheter during itsadvancement. As soon as blood is drawn into the outer lumen through theindicator hole, advancement of the catheter and retractor are stopped.The two halves of the retracting portion are then separated to exposethe wound, the catheter and guidewire are removed, and the wound isclosed.

Further, a second catheter having an inflatable balloon on its distalend may be used. Once the retractor and double-lumen catheter are inplace, the guidewire is removed from the patient through the inner lumenof the dual-lumen catheter. The inner catheter having an inflatableballoon mounted on its distal end is inserted through the inner lumen ofthe dual-lumen catheter and into the patient. Once inside thevasculature, the balloon is inflated and drawn in a proximal directionuntil resistance is felt. This helps to anchor the catheter in place aswell as stop the bleeding during the closing of the wound. Thedual-lumen catheter is removed, and the inner catheter is used to guidea closing device to the wound. The wound is closed as the balloon isdeflated and the inner catheter is removed. Finally, the retractor isremoved.

The present invention advantageously provides a simple and safe methodof facilitating the closure of a wound in the vasculature of a patient,and the devices which facilitate this method. A retractor, used inconjunction with a guidewire, dilator or catheter, helps locate andisolate the site of the puncture wound in the patient. The retractormoves the surrounding tissue laterally as it is advanced into thepatient, and acts as a guide for the physician in locating the exactsite of the wound. The retractor is preferably used in combination witha surgical clip applicator which delivers clips to the site of thewound, but can also be used with other methods of wound closure such assuturing and stapling. The present invention eliminates the prolongedbleeding associated with current cardiac diagnostic and therapeuticprocedures, and provides a significant advancement in the medical field.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a portion of a human body, showing the sitewhere the femoral artery is typically accessed and punctured duringangioplasty or angiography.

FIG. 2 is a perspective view of one embodiment of the wound closuredevice of the present invention.

FIG. 3 is an exploded perspective view of the wound closure device ofthe present invention.

FIG. 4 is a cross-sectional view of a portion of a human body, showingthe femoral artery accessed via a hollow needle, and a guidewire havingan inflatable balloon attached, inserted through the hollow needle andinto the femoral artery.

FIG. 5 is a side view of the distal end of a surgical clip applicator tobe used in conjunction with the wound closure device of the presentinvention.

FIG. 6 is a partial cross-sectional view of a portion of a human body,showing the femoral artery having a guidewire positioned therein, and aperspective view of the retractor of the present invention positionedover the guidewire, with its distal tip at the site of the puncture inthe femoral artery.

FIG. 7 is a side view of the retractor with its cap removed and thewings of the surgical clip applicator inserted into the grooves withinthe retractor.

FIG. 8 is a cross-sectional view of the clip applicator and retractortaken along line 8—8 in FIG. 7.

FIG. 9 is a perspective view of an alternate embodiment of a femoralartery closure device in accordance with the present invention.

FIG. 10 is an exploded perspective view of the alternate embodiment ofthe femoral artery closure device illustrated in FIG. 9.

FIG. 11 is a side view of the 2 halves of the retractor of FIGS. 9 and10 separated slightly and having a dilator inserted therethrough.

FIG. 12 is a cross-sectional view of the distal end of the retractorhaving a dilator and a guidewire inserted therethrough.

FIG. 13 is a side view of the components of the femoral arterylocalization and closure assembly.

FIG. 14 is a side view of the 2 halves of the retractor separatedslightly and having a surgical clip applicator with an applicator guideand a guidewire inserted therethrough.

FIG. 15 is a top view of the surgical clip applicator guide of thepresent invention.

FIG. 16 is a side view of the clip applicator guide, having a guidewireinserted therethrough.

FIG. 17 is an enlarged perspective view of a dilator having a removabledouble-sleeved balloon at its distal end.

FIG. 18 is an enlarged perspective view of the dilator of FIG. 17 withthe sleeves of the balloon inflated.

FIG. 19 is an enlarged perspective view of the dilator of FIG. 18 havingthe retractor inserted between the sleeves of the balloon.

FIG. 20 is an enlarged perspective view of the dilator and retractor ofFIG. 19 with the dilator removed, illustrating the tunnel formed by theretractor and the outer sleeve of the balloon.

FIG. 21 is a perspective view of another alternate embodiment of aretractor in accordance with the present invention.

FIG. 22 is an exploded perspective view of the alternate embodiment ofthe retractor illustrated in FIG. 21.

FIG. 23 is a perspective view of an alternate embodiment of a dilatorhaving a double-sleeved balloon and a distal balloon mounted thereon inaccordance with the present invention.

FIG. 24 is a top view of another embodiment of the double-sleevedballoon, illustrating the I-shaped inner sleeve.

FIG. 25 is a perspective view of the alternate embodiment of the dilatorof FIG. 23, showing the balloons inflated.

FIG. 26 is a cross-sectional view of the dilator of the presentinvention, illustrating the various lumens in the dilator.

FIG. 27 is a side view of the distal end of a surgical clip applicatorwith an indicator tube mounted thereon.

FIG. 28 is a perspective view of an alternate embodiment of a retractorof the present invention, shown in a closed position.

FIG. 29 is a perspective view of an alternate embodiment of a retractorof the present invention, shown in an open position.

FIG. 30 is a side view of a dual-lumen indicator tube of the presentinvention, having a guidewire inserted through its central lumen.

FIG. 31 is a side view of the dual-lumen indicator tube of the presentinvention, with the retractor mounted thereon.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Introduction

Although the description which follows details the closure of a puncturewound in a femoral artery, the present invention is not intended to belimited to use only with the femoral artery. Rather, the descriptionwhich follows is exemplary only, and those of skill in the art canreadily modify the method described below to use with other types ofwounds to the vascular system.

Referring first to FIG. 1, there is shown a side view of a portion of ahuman body, showing a site 5 where a femoral artery 10 is typicallyaccessed and punctured during angioplasty or angiography. During theseprocedures, a hollow needle 15 is first inserted through the skin andinto the femoral artery 10. A guidewire 20 is then inserted through theproximal end of the hollow needle 15 and into the artery 10, asillustrated in FIG. 4, and the needle 15 is withdrawn from the patient.The guidewire 20 is advanced through the patient's vasculature, oftenusing x-ray imaging as an aid in directing the guidewire 20 to thedesired location.

Once the guidewire 20 is in the desired location, a catheter is used.The proximal end of the guidewire 21 is inserted into the distal end ofthe catheter, and the catheter is threaded over the guidewire 20 andadvanced to the desired location. In the case of angioplasty, thecatheter has an inflatable balloon attached at its distal end. Once inposition within the stenosis, the balloon is repeatedly inflated anddeflated to widen the narrowed blood vessel. In the case of angiography,a catheter is threaded over the guidewire 20 as just described and intothe blood vessel to be examined. Contrast medium is then injected, and arapid sequence of x-ray pictures are taken so that blood flow along theaffected vessel can be studied.

After either of these procedures is completed, the catheter andguidewire 20 are withdrawn from the blood vessel and the patient. Thepuncture wound 25 in the femoral artery 10 caused by the insertion ofthe hollow needle 15, guidewire 20 and catheter must be closed and thebleeding through the puncture site 25 in the artery 10 stopped.

Construction of the Retractor

In order to facilitate the closure of the wound 25 in the femoral artery10, a retractor 30 is employed. The retractor 30, illustrated in FIGS. 2and 3, comprises a body portion 35 and a cap 40. The body 35 of theretractor 30 has a narrow, tapered distal end 37, and a broader circularproximal end 41. The device 30 has two handles 43, 45 located on itsbody 35, one on each half 35 a, 35 b. The handles 43, 45 are positionedapproximately one-third of the way from the proximal end of theretractor 41, and extend laterally from the body of the retractor 35.These handles 43, 45 assist the user in handling the device 30. Theretractor 30 also comprises a circular cap 40 at its proximal end 41,having a hole 47 therethrough. This hole 47 extends into a channel 50which runs the entire length of the device 30.

As illustrated in FIG. 3, the cap 40 and body 35 of the retractor 30comprise three separable pieces: the cap portion 40 and the two halvesof the body portion 35 a, 35 b. The removable cap 40 is internallythreaded 55. The proximal end 39 of the two halves of the body 35 a, 35b are externally threaded 60, and are adapted to removably receive thecap 40. Each half of the body of the retractor 35 a, 35 b has asemi-circular groove 65 on its flat internal surface 67. When the cap 40is securely screwed onto the two halves of the body 35 a, 35 b asillustrated in FIG. 2, the three pieces are joined together, and thesemi-circular grooves 65 form a channel 50 running through the interiorof the device 30, which starts at the hole in the cap 47 at the proximalend 41 and continues through the body 35, ending at a small hole 49 inthe distal end of the retractor 37 where the two halves of the body 35a, 35 b come together. When the cap 40 is unscrewed from the body 35,the two halves of the body 35 a, 35 b may be moved apart from oneanother, as illustrated in FIG. 3.

Alternate Embodiment of the Retractor

Another preferred embodiment of the invention is illustrated in FIGS.9-10. In this embodiment, the retractor 100 includes a retractionmechanism whereby the two halves 102 a, 102 b of the retractor body 102can be moved apart from one another a desired distance, whilemaintaining their alignment. The retractor again comprises a bodyportion 102, and an annular cap 104. The two halves 102 a, 102 b of thebody are initially held together by the internally threaded 105 cap 104.This cap 104 is screwed on and off the externally threaded halves 102 a,102 b of the retractor body. The outer surface of the cap 106 can betextured to ease hand tightening and loosening of the cap 106. Asillustrated in FIG. 10, each half 102 a, 102 b of the retractor bodyagain has a semicircular groove 126 running longitudinally down thecenter of its flat internal surface 128. When the cap 104 is securelyscrewed onto the two halves 102 a, 102 b of the retractor body, suchthat the internal surfaces 128 abut one another, the semicirculargrooves 126 form a channel 108. The cap 104 is open on both ends andthrough its center to permit access to the channel 108.

The retractor 100, as illustrated in FIGS. 9-10, further comprises acollar 110 located on the retractor body 102 just distal to theexternally threaded proximal end 103; a pin assembly 116, comprising twoparallel pins 116 a, 116 b attached at one end to a perpendicular handle116 c; and two set screws 120 a, 120 b. As illustrated in FIG. 10, thepins 116 a, 116 b traverse guide passages 118 a, 118 b bored through thecollar region 110 b of one half 102 b of the retractor body and areinsertable within holes 124 a, 124 b in the collar region 110 a of theother half 102 a of the retractor body, such that one half 102 b of theretractor body can slide apart from the other half 102 a on the pins 116a, 116 b. The collar 110 b includes internally threaded holes 122 a, 122b adapted to receive externally threaded set screws 120 a, 120 b. Theset screw holes 122 a, 122 b enter the collar region 110 a at rightangles to the pin guide passages 118 a, 118 b, such that when the setscrews 120 a, 120 b are advanced, they tighten upon the pins 116 a, 116b and thus, fix the distance between the two halves 102 a, 102 b of theretractor body.

Second Alternate Embodiment of the Retractor

Yet another embodiment of the retractor of the present invention isillustrated in FIGS. 21 and 22. The retractor 200 comprises a bodyportion 202 having a distal end 204, and a broader, collar portion 206at its proximal end 205. Like the embodiment described above, thisretractor 200 is formed in two halves 202 a, 202 b and preferably has atapered distal end 204. Each half of the body of the retractor 202 a,202 b, has a semi-circular groove 208 on its flat internal surface 209.When the two halves 202 a, 202 b are joined together, the semi-circulargrooves 208 form a channel 210 running through the interior of thedevice 200, extending from the proximal end 205 to the distal end 204.

The collar 206 of the device 200 includes a pin assembly 212 comprisingtwo parallel pins 212 a, 212 b attached at one end to a handle 212 c,and two set screws 214 a, 214 b. As illustrated in FIG. 22, the pins 212a, 212 b traverse guide passages 216 a, 216 b bored through the collarregion 206 of one half of the retractor body 202 b, and are insertablewithin holes 218 a, 218 b in the collar region 206 of the other half ofthe retractor body 202 a, such that one half of the retractor body 202 bcan slide apart from the other half 202 a on the pins 212 a, 212 b. Thecollar 206 also includes internally threaded holes 220 a, 220 b adaptedto receive externally threaded set screws 214 a, 214 b. The set screwholes 220 a, 220 b enter the collar region 206 at right angles to thepin guide passages 216 a, 216 b such that when the set screws 214 a, 214b are advanced, they tighten upon the pins 212 a, 212 b and thus, fixthe distance between the two halves of the retractor body 202 a, 202 b.

Third Alternate Embodiment of the Retractor

Still another embodiment of the retractor of the present invention isillustrated in FIGS. 28 and 29. The retractor 300 comprises a distalbody portion 302, and a proximal handle portion 304. The distal bodyportion 302 of the retractor 300 is formed in two portions or halves 302a, 302 b. At the distal end 306 of the body portion 302, a retractingportion 308 extends away from, and at an angle to the body portion 302.Preferably, the retracting portion 308 extends substantiallyperpendicular to the body portion 302. The retracting portion 308 isalso formed in two separable portions or halves 308 a, 308 b. Each ofthese portions 308 a, 308 b can be semi-circular in shape, or have asemi-circular groove 312 in its flat, internal surface (FIG. 29). Theexternal surfaces are preferably rounded, and tapered toward the distalend 310. When the two portions 308 a, 308 b are brought together suchthat the two portions abut one another, as seen in FIG. 28, a channel314 is formed through the interior of the retracting portion 308 of theretractor 300.

Handles 316 a, 316 b are located at the proximal end 304 of theretractor 300. The handles 316 a, 316 b are preferably elongate and of adimension sufficient to permit manipulation by hand. The handles 316 a,316 b are securely connected to the body portion 302 of the retractor300. The handles 316 a, 316 b are used to control the movement of theretracting portion 308 of the retractor 300.

FIGS. 28 and 29 also illustrate a loop 320 extending from one of thehandles 316 a in the direction of the other handle 316 b. The otherhandle 316 b has a screw 322 inserted therethrough. The loop 320surrounds the screw 322, such that when the screw 322 is tightened, theloop 320 is held securely between the screw 322 and the underlyingsurface. This mechanism acts to control the distance between the handles316 a, 316 b thereby controlling the distance between the two halves ofthe retracting portion 308 a, 308 b. The handles 316 a, 316 b, and thecorresponding retracting portions 308 a, 308 b may be locked into anyposition by sliding the loop 320 along the screw 322, then tighteningthe screw 322 to securely fix the loop 320 in the desired position. Ofcourse, other locking mechanisms well known to those of skill in the artmay also be used to control the positioning of the retractor 300.

The retractors of the present invention are preferably formed of one ofmany strong, biocompatible engineering polymers. Plastics such aspolypropylene, polyethylene, or polyterephthalate, are preferred.Elastomers such as silastics or silicones can also be used. Mostpreferably, metals such stainless or surgical steel, or titanium, areused to form the retractor.

Construction of the Dilator

As illustrated in FIGS. 11-13, the retractor 100 is preferably used inconjunction with a dilator 150. As is known to those of ordinary skillin the art, the hollow dilator 150 preferably includes a standard maleconnector 149, such as a Luer connector, at its proximal end and isnarrowly tapered at its distal end 151. The inside diameter of thedilator channel 160 is large enough to accommodate a guidewire 144, sothat the dilator 150 can be fed along the guidewire 144 and into thelumen of the femoral artery. Dilators are commonly used in proceduressuch as angioplasty and angiography to enlarge the puncture site andprovide improved access to the femoral artery.

In one embodiment of the present invention, the dilator is preferablynotched 152 near its distal end 151 around its entire circumference.This notch 152 provides a seat for the tapered distal tips of the twohalves 102 a, 102 b of the retractor body, such that when the retractor100 is closed upon the dilator 150, the sharp distal tip of theretractor body 112 is buried in the notch 152 of the dilator. This formsa smooth transition between the dilator 150 and retractor 100 (FIG. 12).As will be explained more fully below, when the guidewire 144 isinserted through the dilator 150 and the dilator 150 is then insertedthrough the retractor 100, (FIGS. 12-13), the dilator 150 lies securelywithin the interior circular channel 108 (FIG. 9) running the length ofthe retractor body 102.

The dilator 150 also preferably includes at least one indicator hole154. The dilator 150 illustrated in FIGS. 11-13 includes two indicatorholes 154 directly opposed to one another, located a few millimetersdistal to the notch 152; the distance X between the holes 154 and thenotch 152 is preferably only slightly larger than the thickness of thewall of the femoral artery.

Alternatively, a transducer-tipped pressure monitoring catheter, mountedto the outside of the dilator 150, may be used in conjunction with thedilator 150 and indicator holes 154. Use of the indicator holes 154 andpressure sensor will be described in detail below.

Dilator/Retractor Assembly

Another embodiment of the present invention comprises an entire femoralartery localization and closure assembly illustrated in FIG. 13. Theguidewire 144 which emerges from the original puncture wound is fedthrough the dilator 150, and then the dilator 150 is inserted throughthe retractor 100. The retractor 100 is advanced along the dilator 150until the distal tips of the retractor 112 stop within the notch 152 inthe dilator 150. Preferably, the male fitting 149 on the proximal end ofthe dilator 150 is connected to one port of a commercially available3-way Y-connector 156. A syringe 158 or other means of applying negativepressure is connected to one of the other ports on the Y-connector 156and the proximal end of the guidewire 144 exits the Y-connector 156 viathe remaining port. The Y-connector 156 therefore acts as a seal at theproximal ends of dilator 150 and guidewire 144.

Alternate Embodiments of the Dilator

In another embodiment of the invention, a modified dilator 150 is used.As illustrated in FIG. 17, a double-sleeved balloon 170 is removablyattached to the dilator 150 near its distal end 151, proximal to asingle indicator hole 154. Preferably, the balloon 170 is placed adistance from the indicator hole 154 which is approximately the width ofthe arterial wall, e.g., about 1.5 mm. The inflatable, double-sleevedballoon 170 is angled at its distal end 172 to allow the balloon tobetter fit the femoral artery 10. The balloon 170 includes inflationmeans which allow the balloon to be inflated and deflated from theproximal end of the dilator 150. Use of the double-sleeved balloon 170will be described in detail below.

In yet another embodiment, illustrated in FIGS. 23-25, the dilator 220has both a double-sleeved balloon 222 and a second inflatable balloon224 mounted on its distal end 226. The double-sleeved balloon 222 isremovably attached to the dilator 220 near its distal end 226, proximalto the single indicator hole 228. The second inflatable balloon 224 ismounted on the dilator 220 just distal to the indicator hole 228. Wheninflated, this second balloon 224 helps anchor the dilator 220 in placein the femoral artery 10, preventing the dilator 220 from being pulledout of the artery 10 during the procedure. Thus, the distal, secondballoon 224 is positioned together with the indicator hole 228, withinthe artery 10, while the double-sleeved balloon 222, proximal to theindicator hole 228, remains outside of the artery 10 as illustrated inFIG. 25. The balloons 222, 224 assist in the proper positioning of thedilator 220, and help anchor the dilator 220 once it is properlypositioned, as will be explained in detail below.

The inner sleeve 230 of the double-sleeved balloon 222 is preferablyshaped to facilitate the insertion of the retractor 200 between the twosleeves 229, 230, as will be described in more detail below. Asillustrated in FIG. 24, the inner sleeve 230 can be in the shape of an“I”, thus providing additional space between the inner surface of theouter sleeve 229, and the outer surface of the inner sleeve 230. Thisallows the two halves of the retractor body 202 a, 202 b to be insertedbetween the two sleeves 229, 230 more easily. The two sleeves of theballoon 229,230 can be shaped in any form that would help facilitateinsertion of the retractor 220.

The dilator 200 having both a double-sleeved balloon 222 and a second,distal balloon 224, is further illustrated in FIG. 26. As can be seenfrom the drawing, the dilator 200 has 4 different lumens 232, 234, 236,238 extending from the proximal end of the dilator 225 to the distal endof the dilator 226. A guidewire 240 is inserted through one of thelumens 236. Another lumen 232 is used to inflate the double-sleevedballoon 222, while a third lumen 238 is used to inflate the secondballoon 224 at the distal end of the dilator 226. The fourth lumen 234is used to aspirate blood through the indicator hole 228 at the distalend of the dilator 226. Syringes are preferably used to provide theaspiration and inflation pressure through these lumens 232, 234, 236,238. The proximal end of the dilator 225 is preferably adapted to allowfor fluid communication between the syringes and the various lumens 232,234, 236, 238 in the dilator. Of course, other means of aspirating bloodand inflating the balloons may also be used, and connectors specificallyadapted for these devices can be attached at the proximal end of thedilator 225 to accommodate the means chosen.

Dual Lumen Catheter

In yet another embodiment of the invention, a dual-lumen catheter isused to locate the exact site of the puncture wound. As illustrated inFIGS. 30 and 31, the catheter 340 has an inner lumen 342 which extendsfrom the proximal end of the catheter 344 all the way to the distal endof the catheter 346. This inner lumen 342 is adapted to receive an innercatheter 360 or guidewire 350, as will be explained in more detailbelow.

The outer lumen of the dual-lumen catheter 340 surrounds the inner lumen342, and also extends from the proximal end of the catheter 344 to thedistal end 346. Near the distal end of the catheter 346, at least oneindicator hole 352 is positioned in the outer wall of the catheter 340.The indicator hole 352 provides fluid communication between the areaoutside of the catheter 340 and the outer lumen. The outer surface ofthe catheter 354 surrounding the indicator hole 352 is preferablyraised, acting as a stop. Preferably, the distance between the indicatorhole 352 and the proximal end of the raised surface of the retractor354, is approximately the same as the thickness of the wall of thefemoral artery. As will be explained below, the retractor 300 is firstmounted on the distal end of the catheter, and positioned such that thedistal tip of the retracting portion 310 stops just proximal to theraised surface 354, about 0.5 mm proximal to the indicator hole 352.This assures that the distal tip of the retracting portion 310 will beproperly positioned inside the patient's body at the site of the woundin the artery.

At the proximal end of the catheter 344, the proximal end 358 of theouter lumen is preferably joined to a connector 364, such as a Luer-typeconnector, which is adapted to receive a syringe 360 or other source ofnegative pressure, as will be explained in more detail below.

The Surgical Clip Applicator

The retractor of the present invention is used to facilitate closure ofwounds to the vasculature of a patient using surgical clips, staples, orsutures. One aspect of the present invention therefore includes the useof a surgical clip applicator 70. A surgical clip applicator 70 for usewith the retractor 30 of the present invention is illustrated in FIG. 5.As shown in this figure, the distal end of the clip applicator 75 isfitted with two triangular protrusions or wings 77 a, 77 b that extendlaterally from the sides of the distal end of the clip applicator 75.These wings 77 a, 77 b are configured to fit within the grooves 65located on the interior surface of the two halves 35 a, 35 b of the bodyof the retractor 30, as is best seen in FIG. 8. With the wings 77 a, 77b of the clip applicator 70 in the grooves 65 in the two halves of thebody of the retractor 35 a, 35 b, the clip applicator 70 is guided intoproper position within the patient's body, as will be discussed in moredetail below. In addition, the surgical clip applicator 70 preferablyhas a guide 80 attached to its distal end 75. The guide 80 preferablyextends laterally from the side of the clip applicator 70, and is openat its proximal and distal ends such that a guidewire 20 may be threadedtherethrough. This guide 80 is used in combination with the guidewire 20to accurately guide the clip applicator 70 to the site of the vascularpuncture 25, as will be described below.

The surgical clip applicator 70 preferably also has a stop 85 locatedproximal of the distal end 75, at the point where the proximal ends ofthe wings of the applicator 77 a, 77 b end. As will be explained, thestop 80 also aids in the proper positioning of the clip applicator 70 atthe site of the vascular puncture 25, and prevents the clip applicator70 from being inserted too far into the patient's body.

Alternate Surgical Clip Applicator Assembly

Referring now to FIGS. 14-16, there is illustrated an alternateembodiment of a surgical clip applicator assembly 130. The clipapplicator assembly 130 incorporates a standard commercially availablesurgical clip applicator 132. In accordance with the present invention,the applicator is modified to include a guide assembly 134 reversiblyfastened near its distal end. The guide assembly comprises a wingedguide plate 138 which is reversibly secured to a body 140. In theembodiment illustrated in FIGS. 14-16, allen screws 142 are used toattach the guide plate 138 but other well known means of attachment canalso be used. The distal end of the surgical clip applicator 132 slideswithin the channel 148 (FIG. 15) formed when the winged guide plate 138is fastened to the guide body 140.

Attached to the guide body 140 is a guidetube 136 which is adapted toaccept the guidewire 144. A preferred embodiment of said guidetube 136includes a mechanism to close the guidetube 136 once the guidewire 144has entered. Such a mechanism may involve a second partially open tubewhich fits within said guidetube 136. This second tube can be rotatedwithin the guidetube 136 to open the guidetube 136 when the openings inboth tubes are aligned or close the guidetube 136 when the openings ofthe tubes are offset. To facilitate the opening and closing, the innertube preferably includes a handle that passes through a slot in theouter guidetube 136. This mechanism can be spring-loaded like theclosures commonly used on pieces of jewelry.

The surgical clip applicator guide assembly 134, together with theretractor 100 and the guidewire 144, is designed to accurately guide theclip applicator 132 to the site of the femoral artery puncture asdetailed below. As explained above, the lateral edges of the wingedguide plate 138 are configured to fit within the groove 126 (FIG. 10)located on the interior surface of each half of the retractor body 102a, 102 b. The surgical clip applicator 132 is guided between theretracted halves of the retractor body 102 a, 102 b following theguidewire 144 which passes through the guidetube 136 at the distal mostend of the surgical clip applicator 132.

Second Alternate Surgical Clip Applicator Assembly

An alternate embodiment of the surgical clip applicator assembly 250 isillustrated in FIG. 27. Again, the clip applicator assembly 250incorporates a standard commercially available surgical clip applicator252. The applicator 252 is modified to include a guide assembly 254reversibly fastened near its distal end 256. The guide assembly 254 isadapted to receive an indicator tube 260. The indicator tube 260 is ahollow tube having an indicator hole 264 near its distal end 262. Theindicator tube 260 is adapted to receive a guidewire 240 therethrough,and to be connected to a source of negative pressure at its proximalend. This source of negative pressure, such as a syringe, is used toprovide aspiration through the indicator hole 264. When properlypositioned on the clip applicator 252, the distal end of the indicatortube 262 and the indicator hole 264 extend past the distal end of theclip applicator 256. Preferably, the distance between the indicator hole264 and the distal tip of the clip applicator 256 is approximately equalto the width of the arterial wall, e.g., about 1.5 mm.

Methods of Use

Referring first to FIGS. 4-8, a first method of use of the retractor 30in conjunction with a surgical clip applicator 70 to close a wound 25 inthe femoral artery 10 will now be described. As noted above, duringangioplasty or angiography, the femoral artery 10 is first puncturedwith a hollow needle 15 and a guidewire 20 is inserted therethrough(FIG. 4). A proximal portion of the guidewire 21 remains outside thepatient's body. After the distal end of the guidewire 23 is in positionwithin the femoral artery 10, the hollow needle 15 is removed. Acatheter (not shown) is then threaded over the guidewire 20, andinserted into the patient's body.

In a preferred embodiment, a specially designed guidewire 20 having aninflatable balloon 24 located near its distal end 23 is used for thediagnostic or therapeutic procedure. The guidewire 20 is threadedthrough the hollow needle 15 and into the patient's vasculature.Alternatively, such as for balloon angioplasty procedures, a standardguidewire well known to those of skill in the art can be used inconjunction with a balloon catheter. The balloon on the distal end ofthe catheter can be used in place of the balloon 24 located on theguidewire 20.

Following completion of the therapeutic or diagnostic procedure, thecatheter used during the procedure is removed. The guidewire 20 remainsin place in the patient's vasculature. (Note that when a ballooncatheter is used in place of a guidewire having a balloon on its distalend, the catheter is left inside the patient, and use of its balloon isidentical to the use of the balloon 24 on the guidewire 20 describedbelow).

When the physician desires to close the wound 25 in the femoral artery10, he or she first withdraws the guidewire 20 and/or catheter throughthe patient's vasculature using the portion of the guidewire 20 and/orcatheter that remains outside the patient's body 21, until the distalend 23 of the guidewire 20 and/or catheter is within the femoral artery10 close to the femoral artery puncture site 25. The balloon 24 on thedistal end 23 of the guidewire 20 or catheter is then inflated, and theguidewire 20 or catheter is withdrawn further until the physician feelssome resistance. This will indicate that the balloon 24 is inside thefemoral artery 10 and at the site of the puncture wound 25. Thephysician then threads the proximal end of the guidewire 21 into thehole 49 located at the distal end 37 of the fully assembled retractor 30(FIGS. 2, 3 and 6). The guidewire 20 is threaded through the channel 50formed in the body of the retractor 35, until the proximal end of theguidewire 21 emerges through the hole 47 in the cap 40 at the proximalend of the retractor 41 (FIG. 6). The retractor 30 is then slowlyadvanced along the guidewire 20 and into the patient's body, untilresistance is felt. This resistance indicates that the distal tip of theretractor 37 is contacting the inflated balloon 24 in the femoral artery10. The distal tip of the retractor 37 therefore will be properlylocated at the site of the puncture in the femoral artery 25, as isshown in FIG. 6.

In a preferred embodiment, the guidewire 20 used in conjunction with thefemoral artery closure retractor 30 has a marking 27 on it which alsohelps to indicate when the retractor 30 has been properly positioned(FIG. 6). This marking 27 preferably consists of a tiny bead or coloredline on the guidewire 20. The marking on the guidewire 27 is placedproximal of the proximal end of the balloon 26. The length of theretractor 30 is measured, and the marking 27 is made at least that samelength in a proximal direction on the guidewire 20, measured from theproximal end of the balloon 26. Thus, when the retractor 30 is advancedover the guidewire 20 and resistance is felt, the physician checks tosee if the marking on the guidewire 27 has emerged through the proximalend of the retractor 41, as is illustrated in FIG. 6. If the marking 27is not yet visible, the physician must advance the retractor 30 furtherto ensure that it contacts the femoral artery puncture site 25.

Once the retractor 30 is properly positioned within the patient's body,the surgical clip applicator 70 or other method of closing the puncturewound 25 is used. The cap 40 on the retractor 30 is first removed fromthe body by unscrewing (FIG. 3). The proximal end of the guidewire 21emerging from the proximal end of the retractor 41 is threaded throughthe guide 80 located on the outer surface of the applicator 70, asillustrated in FIG. 7. The wings on the surgical clip applicator 77 a,77 b are inserted into the hole 90 formed at the proximal end of thebody of the retractor 39, by lining up the wings 77 a, 77 b on theapplicator 30 with the grooves 65 located on the inner surface 67 of theretractor body halves 35 a, 35 b (FIGS. 7 and 8). The wings on the clipapplicator 77 a, 77 b are sized to fit within the grooves 65 of theretractor 30, as is best illustrated in FIG. 8. The clip applicator 70is then advanced, which causes the two halves of the body of theretractor 35 a, 35 b to separate, as shown in FIG. 7. As the two halves35 a, 35 b separate, the patient's tissue is displaced laterally,allowing better access to the puncture site 25 in the femoral artery 10below the overlying tissues. The clip applicator 70 is advanced throughthe retractor 30 until the stop on the applicator 85 contacts theproximal end of the retractor 39. At this time, the balloon on theguidewire 24 or catheter is deflated, and the catheter and/or guidewire20 is removed from the patient. The surgical clips located at the distaltip of the clip applicator 75 are applied to the puncture wound 25,using the method well known to those of ordinary skill in the art. Oncethe femoral artery puncture wound 25 is closed, the clip applicator 70and retractor 30 are removed from the patient.

First Alternate Method

Referring now to FIGS. 9-16, a method of using the alternate embodimentof the retractor 100 in conjunction with the dilator 150 and surgicalclip applicator assembly 130 to localize and close the femoral arterypuncture wound is now described. As described above, followingcompletion of the angioplasty or angiography, the catheter used duringthe procedure is removed from the patient's body, leaving only theguidewire threaded into the femoral artery. If desired, before theretractor-dilator assembly 101 (FIG. 13) is used, a standard dilator ofa smaller diameter than that 150 incorporated into the retractor-dilatorassembly 101 can be fed onto the proximal end of the guidewire andadvanced down the guidewire and into the artery. This preliminary stepdilates the overlying tissue if necessary, making it easier tosubsequently pass the larger retractor-dilator assembly 101 through thesurrounding tissue.

If the tissue has been dilated as above, the smaller bore standarddilator is first removed. The proximal end of the guidewire 144 is firstinserted into the distal channel 160 (FIG. 11) of the dilator 150. Thedilator 150 has been previously inserted through the internal channel ofthe retractor 100, and the retractor 100 advanced over the dilator 150until the distal tip 112 comes to rest in the notch 152 on the distaltip of the dilator 150. The Y-connector 156 is then attached to theproximal end of the dilator 150 and a syringe 158 attached to one of theports of the connector 156. The retractor-dilator assembly 101 is thenadvanced over the guidewire 144 into the patient's body.

While the retractor-dilator assembly 101 is advanced into the patient'sbody, suction is continuously applied via the syringe 158 or other meansof negative pressure (FIG. 13) to the dilator 150. At the moment theindicator holes 154 enter the lumen of the femoral artery, blood isaspirated into the syringe 158, indicating that the dilator 150 has beeninserted through the puncture site into the femoral artery. Thus, thedistal tip of the retractor 112, still buried within the notch 152 inthe dilator 150, is located just proximal or outside the artery wall atthe site of the puncture wound and the indicator holes 154 in thedilator 150 are located just distal or inside the artery lumen.

Alternatively, the dilator 150 includes a pressure sensor (not shown)such as a fiber optic pressure sensor, near its distal tip. The sensoris preferably mounted to the outside wall of the dilator 150. In apreferred embodiment, a transducer-tipped pressure monitoring catheter,such as the Camino Catheter available from Camino Laboratories, SanDiego, Calif., is used. The pressure sensor, mounted on the outside ofthe dilator 150, is inserted over the guidewire 144 and into the femoralartery. The pressure sensor, in conjunction with a pressure monitoringsystem, will indicate an increase in pressure when it is inserted intothe femoral artery. At that point, the advancement of the retractor 100is stopped, such that the distal tip of the retractor 112 is locatedjust proximal the artery wall 10 at the site of the puncture wound. Thisallows the physician to properly locate the site of the femoral arterypuncture wound in the patient.

Once the dilator 150 and retractor 100 are in proper position, the cap104 is removed from the retractor 100 and the two halves 102 a, 102 b ofthe retractor body are separated slightly (FIG. 10) by loosening the setscrews 120 a, 120 b and sliding the two halves 102 a, 102 b of theretractor laterally away from one another. This causes the distal tips112 of two halves 102 a, 102 b to emerge from the notch 152 in thedilator 150 (FIG. 11) and straddle the puncture site. The set screws 120a, 120 b, are then tightened to hold the two halves 102 a, 102 b of theretractor 100 in this separated position. While pressing the retractor100 down against the outer wall of the femoral artery, the dilator 150is withdrawn, leaving only the retractor 100 and the guidewire 144 inposition at the site of the puncture wound in the artery.

To close the wound, the retractor 100 must be retracted far enough toallow the surgical clip applicator assembly 130 to access the puncturesite. Upon loosening the set screws 120 a, 120 b, the two halves 102 a,102 b of the retractor are further separated by applying pressure on theretractor pin handle 116 c (FIGS. 9-10). When sufficiently retracted,the set screws 120 a, 120 b on the retractor assembly 100 are tightenedto maintain the proper distance between the retractor halves. Ifnecessary, a separate retractor, having a thickness suited for slidingwithin the grooves 126 in each half 102 a, 102 b of the retractor body,and a width equal to that of the winged guide plate 138 (FIG. 14) of thesurgical clip applicator guide assemble 134, can be used to open theretractor body to the proper distance.

Second Alternate Method

In an alternate embodiment illustrated in FIG. 17, the modified dilator150 having a double-sleeved inflatable balloon 170 removably attached tothe distal end of the dilator 151, just proximal to the indicator hole154, is used. The balloon dilator apparatus 175 is inserted over theguidewire 144 into the patient's body. As described above, as theballoon-dilator apparatus 175 is advanced, negative pressure is appliedto the system via the syringe or other source. The advance of theballoon-dilator apparatus 175 is stopped as soon as blood is aspirated.The double-sleeved balloon 170 is then inflated to form a tunnel 176between the femoral artery puncture wound and the surface of thepatient's body, as illustrated in FIG. 18.

The double-sleeved balloon 170 advantageously prevents the femoralartery closure retractor 100 from entering the femoral artery 10 anddamaging it. Should the deflated balloon 170 be advanced into thefemoral artery 10, the process of inflating the balloon 170 will pullthe balloon 170 out of the artery 10, thereby safely creating a tunnel176 used to access the artery 10.

The balloon 170 is preferably angled at its distal end 172 to allow theballoon 170 to “fit” the femoral artery 10, as shown in FIGS. 17-19.

Once the balloon 170 is inflated (FIG. 18) the retractor 100 is advancedbetween the two sleeves of the balloon 170, until the distal tip of theretractor 112 reaches the distal end of the double sleeved balloon 170.Once the retractor 100 is positioned between the two sleeves of theballoon 170, the two halves of the retractor 102 a, 102 b are movedlaterally away from one another, as described above. The inner sleeve178 and the dilator 150 are removed from the patient, leaving theseparated retractor 100 and the outer sleeve 180 of the balloon 170 inthe patient. The dilator 150 and the inner sleeve 178 are removed fromthe patient along the guidewire 144.

The retractor 100 and the outer sleeve of the balloon 180 form an accesstunnel 182 between the femoral artery puncture wound and the surface ofthe patient's body, as illustrated in FIG. 20. This tunnel 182 allowsfor the introduction of the wound closure device to seal the femoralartery puncture wound.

At this point, with the retractor providing access to the femoralartery, the proximal end of the guidewire 144 is inserted into theguidetube 136 on the surgical clip applicator assembly 130 and the wingson the guide plate are fitted within the grooves 126 of the openedretractor body 102 (FIGS. 14-16). The clip applicator assembly 130 cannow be advanced toward the puncture wound, sliding within the grooves126 in the retractor body 102, guided by the guidewire 144 passingthrough the guidetube 136 at the distal tip of the surgical clipapplicator assembly 130. When the distal tip of the surgical clipapplicator 130 has reached the outer wall of the femoral artery 10, atthe site of the puncture wound, the surgeon withdraws the guidewire 144from the patient's body and immediately deploys a surgical clip. Asecond clip can then be deployed a millimeter or two away from the firstclip in order to ensure that the wound is closed.

In a preferred embodiment, just prior to closure of the puncture site,the flexible guidewire 144 used during the primary procedure is replacedwith a commercially available guidewire that can become rigid at itsdistal end, forming a hook. The hooked distal end can be pulled back,“hooking” the puncture wound in the artery. As the guidewire is pulledback further, the puncture wound is stretched into a linear slit, makingit more amenable to closure by surgical clips.

Third Alternate Method

Referring now to FIGS. 21-27, a method of using the alternate embodimentof the retractor 200 in conjunction with the dilator 220 and surgicalclip applicator assembly 250 to localize and close the femoral arterypuncture wound is now described. As described above, followingcompletion of the angioplasty or angiography, the catheter used duringthe procedure is removed from the patient's body, leaving only theguidewire 240 threaded into the femoral artery 10.

The proximal end of the guidewire 240 is first inserted into the distallumen 236 (FIG. 26) of the dilator 220. The dilator 220 is advanced overthe guidewire 240 into the patient's body. As described above, as theballoon-dilator apparatus 250 is advanced, negative pressure is appliedto the system via the syringe or other source connected at the proximalend of the dilator 225. The advance of the dilator 220 is stopped assoon as blood is aspirated through the indicator hole 228, thusindicating that the distal end of the dilator 226 is positioned withinthe femoral artery 10. The distal balloon 224 and the double-sleevedballoon 222 are then inflated to anchor the dilator 220 in place and toform a tunnel between the femoral artery puncture wound and the surfaceof the patient's body.

Once the balloons 222, 224 are inflated, the retractor 200 is advancedbetween the two sleeves 229, 230 of the double sleeved balloon 222. Asillustrated in FIG. 24, the inner sleeve 230 of the double sleevedballoon 222 can be in an “I” shape, which provides more space betweenthe two sleeves to insert the two halves 202 a, 202 b of the reactor200. The retractor 200 is advanced between the two sleeves 229, 230, asdescribed above, until the distal tip of the retractor 204 is positionedjust proximal to the puncture wound in the femoral artery 10.

Once the retractor 200 is positioned between the two sleeves of theballoon 229, 230, the two halves of the retractor 202 a, 202 b are movedlaterally away from one another. This is done by loosening the setscrews 214 a, 214 b, and sliding one half of the retractor body 202 baway from the other half 202 a on the pins 212 a 212 b. The inner sleeve230 of the double-sleeved balloon 222 and the dilator 220 are removedfrom the patient along the guidewire 240, leaving the separatedretractor 200 and the outer sleeve 229 of the balloon 222 in thepatient. The retractor 200 and the outer sleeve of the balloon 229 forman access tunnel between the femoral artery puncture wound and thesurface of the patient's body. This tunnel allows for the introductionof the wound closure device to seal the femoral artery puncture wound.

At this point, with the retractor 200 and outer sleeve of the balloon229 providing access to the femoral artery 10, the proximal end of theguidewire 240 is inserted into the distal end 262 of the indicator tube260 which is mounted on the surgical clip applicator 252. As describedabove, the distal end 262 of the indicator tube 260 having an indicatorhole 264 in it is positioned so that the indicator hole 264 extends pastthe distal end 256 of the clip applicator 252. The indicator tube 260and the clip applicator 252 are advanced over the guidewire 240 whileaspiration pressure is applied to the proximal end of the indicator tube260. As soon as blood is aspirated through the indicator hole 264, theadvancement of the indicator tube 260 and clip applicator 256 isstopped. At this point, the distal end of the surgical clip applicator256 is positioned at the site of the puncture wound in the femoralartery 10. Surgical clips are then applied to seal the wound.

Preferably, the distal end of the indicator tube 262 is curved orhooked. The hooked distal end is used to hook the puncture wound in theartery, bringing the edges of the wound together to facilitateapplication of the clip. Using the hooked distal end 262 of theindicator tube 260, the puncture wound is stretched into a linear slit,making it more amenable to closure by surgical clips.

Fourth Alternate Method

Referring now to FIGS. 28-31, still another method of closing a wound inthe femoral artery of a patient will be described. Here again, thefemoral artery is first punctured with a hollow needle and a guidewire350 is inserted therethrough. A proximal portion of the guidewire 351remains outside the patient's body. After the distal end of theguidewire 353 is in position within the femoral artery, the hollowneedle is removed. Diagnostic and/or therapeutic procedures are thencarried out, using the guidewire 350 to guide the insertion of the othermedical instruments into the vasculature of the patient.

Following completion of the therapeutic or diagnostic procedure, thedevices used during the procedure are removed. The guidewire 350 remainsin place in the patient's vasculature. When the physician desires toclose the wound in the artery, he or she first mounts the retractor 300on the distal end of the dual-lumen catheter 340. This is done byloosening the screw 322 on one of the handles 316 b, and moving thehandles 316 a, 316 b away from one another to separate the two halves ofthe retracting portion 308, and the two parts of the retracting portion308 a, 308 b are positioned around the dual-lumen catheter 340. The duallumen catheter 340 fits within the semicircular channel or grooves 312formed in the inner surface of the retracting portion 308 of theretractor 300. The two halves of the retracting portion 308 a, 308 b arebrought together using the handles 316 a, 316 b to surround the catheter340. The retracting portion 308 is positioned on the catheter 340 justproximal to the raised portion of the catheter 354, so the distal tip ofthe retracting portion 310 is located just proximal to the indicatorhole 352. Preferably, the distal tip of the retracting portion 308 willbe approximately 0.5 mm behind the indicator hole 352 (see FIG. 31).Once in position, the screw 322 is tightened on the loop 320 to lock thetwo parts of the retracting portion 308 a, 308 b in position on thecatheter 340.

Once the retractor 300 is properly positioned on the dual-lumen catheter340, the physician inserts the proximal end 351 of the guidewire 350into the distal end of the inner lumen 342 in the dual-lumen catheter340. The dual-lumen catheter 340 and retractor 300 are advanced over theguidewire 350 and into the patient. As the catheter 340 and retractor300 are advanced, negative pressure is applied to the outer lumen of thecatheter, for example, through use of a syringe 360 attached to theproximal end of the outer lumen 358. Once the indicator hole 352 isadvanced to a position inside the artery, blood will be drawn throughthe indicator hole 352 and will become visible in the outer lumen of thecatheter 340 and the syringe 360. At this point, advancement of thecatheter 340 and retractor 300 are stopped, as the catheter 340 andretractor 300 are properly positioned in the patient.

Once properly positioned at the site of the puncture wound, the twohalves of the retracting portion 308 a, 308 b are separated slightly,using the handles 316 a, 316 b at the proximal end 304 of the retractor300. To separate the retracting portions 308 a, 308 b, the screw 322 isloosened, and the handles 316 a, 316 b manipulated into the desiredposition. The screw 322 is then tightened down upon the loop 320,prohibiting further movement of the handles 316 a, 316 b, and thecorresponding retracting portions 308 a, 308 b.

At this point, the surrounding tissues have been displaced, forming anaccess path to the puncture wound, and the puncture wound may bevisible. The dual-lumen catheter 340 is removed from the patient bywithdrawing it over the guidewire 350. The guidewire 350 is left inplace, and the wound closure device, such as a clip applicator, isinserted over the guidewire 350 to the site of the wound. Clips, such asthose made of titanium or a biodegradable material, are applied to thewound, as the guidewire 350 is removed. If necessary, the artery iscompressed to stop the flow of blood out of the puncture wound duringthe closing of the wound. The closing device is removed when thephysician is confident that the wound is closed, and the retractor 300is removed from the patient.

Alternatively, a separate inner catheter 360 is used in the system ofpresent invention. In this embodiment, once the retractor 300 anddual-lumen catheter 340 are in place, and the retracting portion 308 isin an open position, the dual-lumen catheter 340 is left in place, andthe guidewire 350 is withdrawn from the patient through the inner lumen342. An inner catheter 360 having an inflatable balloon 362 at itsdistal end is inserted through the inner lumen 342 and into the patient.Once the distal balloon 362 is advanced past the distal tip 346 of thedual-lumen catheter 340, the balloon 362 is inflated. The dual-lumencatheter 340 is removed from the patient, leaving the inner catheter 360in place.

To properly position the balloon inside the patient's artery, thephysician can measure the distance from the distal tip of the dual-lumencatheter 346 to just outside the patient's body when the catheter 340 isproperly positioned. The physician then inserts the inner catheter 360just slightly more than that distance, to ensure that the distal balloon362 is within the artery. The physician then pulls the inner catheter360 in a proximal direction until resistance is felt. This will placethe balloon 362 at the site of the puncture would. The balloon 362 isproperly positioned just inside the artery of the patient. The balloon362 helps to stop the flow of blood out of the puncture wound. The innercatheter 360 is used as a guide for the clip applicator or other closingdevice used to close the wound. The closing device is advanced until itcontacts the inflated balloon 362. As the wound is closed, the balloon362 is slowly deflated, and the inner catheter 360 is removed from thepatient. Finally, once the physician is confident that the wound isclosed, the retractor 300 is removed from the patient.

The present invention can also be used with surgical staples or sutures.After the retractor is inserted into the patient's body and positionedat the puncture site as described above, the two halves of the retractorare separated, laterally displacing the tissues surrounding the puncturesite. The retractor acts much like a dilator, gradually increasing thedisplacement of the overlying tissues, until the puncture wound isvisible to the physician. The wound can then be closed using anyacceptable means for wound closure, including surgical staples andsutures.

Although certain embodiments and examples have been used to illustrateand describe the present invention, it is intended that the scope of theinvention not be limited to the specific embodiments set forth herein.The scope of the invention is to be defined by the claims which follow.

What is claimed is:
 1. A device to facilitate the closure of wounds inthe vasculature of a patient, comprising: a body portion having aretracting portion having two elongate movable halves extending awayfrom and substantially perpendicular to said body portion, said halvesforming a channel extending completely through said retracting portion,each half having a first end and a second end, the first end beingpositioned farther from the body portion than the second end, the halvesbeing movable between a retracted position and an approximated position;and a handle portion connected to said body portion which controls themovement of the two movable halves, the handle having a grasp portionand a locking mechanism, the grasp portion having two handles, thelocking mechanism selectively engagable so as to prevent movement of thehalves from the retracted position toward the approximated position, thelocking mechanism comprising a loop extending from one handle whichsurrounds a screw mounted on the other handle.
 2. A device to facilitatethe closure of wounds in the vasculature of a patient, comprising: abody portion having a retracting portion having two elongate movablehalves extending away from and substantially perpendicular to said bodyportion, said halves forming a channel extending completely through saidretracting portion, each half having a first end and a second end, thefirst end being positioned farther from the body portion than the secondend, the halves being movable between a retracted position and anapproximated position; a handle portion connected to said body portionwhich controls the movement of the two movable halves, the handle havinga grasp portion and a locking mechanism, the locking mechanismselectively engagable so as to prevent movement of the halves from theretracted position toward the approximated position; and a dual-lumencatheter, having an inner lumen having a proximal end and a distal end,the inner lumen adapted to receive a guidewire therethrough, and anouter lumen having a proximal end and a distal end, the outer lumensurrounding the inner lumen, and the catheter can be inserted throughsaid channel in said retracting portion of said retractor.
 3. The deviceof claim 2, wherein said outer lumen further comprises at least oneindicator hole located in an outer wall of said outer lumen.
 4. Thedevice of claim 3, further comprising a source of negative pressure influid communication with said proximal end of said outer lumen.
 5. Amethod for facilitating the closure of a wound in the vasculature of apatient, comprising the steps of: inserting a guidewire having aproximal end and a distal end into said vasculature through said wound,until said distal end of said guidewire is within the vasculature andthe proximal end remains outside the patient; mounting a retractorcomprising a body portion having a retracting portion having two movablehalves extending away from and substantially perpendicular to said bodyportion, said halves forming a channel extending completely through saidretracting portion; on a distal end of a dual-lumen catheter having aninner lumen and an outer lumen each having a proximal end and a distalend, wherein said outer lumen surrounds the inner lumen, and having atleast one indicator hole located in an outer wall of said outer lumennear the distal end of said outer lumen; inserting the proximal end ofthe guidewire into the distal end of the inner lumen of the dual-lumencatheter; advancing said catheter and retractor over the guidewire untilthe indicator hole enters said wound; separating the two halves of theretracting portion; and closing said wound.
 6. The method of claim 5,wherein said advancing the catheter step further comprises providing asource of negative pressure at the proximal end of said outer lumen, andwherein said advancing step is stopped when blood is drawn into theouter lumen.
 7. The method of claim 5, further comprising the steps of:removing said guidewire from the patient through said inner lumenfollowing said separating step; inserting an inner catheter having aninflatable balloon mounted on its distal end through said inner lumenand into said patient; and inflating said balloon prior to said closingstep.
 8. The method of claim 5, wherein prior to said closing step, thecatheter is removed from the patient and a clip applicator is insertedover the guidewire and advanced to the wound.
 9. The method of claim 5,wherein said closing step comprises applying at least one clip to thewound using said clip applicator.
 10. A device to facilitate the closureof wounds in the vasculature of a patient, comprising: a body portionhaving a retracting portion having two elongate movable halves extendingaway from and substantially perpendicular to said body portion, saidhalves forming a channel extending completely through said retractingportion, each half having a first end and a second end, the first endbeing positioned farther from the body portion than the second end, thehalves being movable between a retracted position and an approximatedposition; a handle portion connected to said body portion which controlsthe movement of the two movable halves, the handle having a graspportion and a locking mechanism, the locking mechanism selectivelyengagable so as to prevent movement of the halves from the retractedposition toward the approximated position; a hollow catheter having anopen proximal end and an open distal end, adapted to receive a guidewiretherethrough, and said hollow catheter can be inserted through saidchannel in said retracting portion of said retractor; and a clipapplicator adapted to receive a guidewire.
 11. A system for facilitatingthe closure of wounds in the vasculature of a patient, comprising: aretractor comprising a body portion having a retracting portion havingtwo movable halves extending away and substantially perpendicular tofrom said body portion, said halves forming a channel extendingcompletely through said retracting portion; and a handle portionconnected to said body portion which controls the movement of the twomoveable halves; a hollow catheter having an open proximal end and anopen distal end, adapted to receive a guidewire therethrough, whereinsaid hollow catheter can be inserted through said channel in saidretracting portion of said retractor; and a clip applicator adapted toreceive said guidewire.
 12. A surgical apparatus, which comprises aretractor and a catheter, the retractor including an elongated bodyportion having proximal and distal ends and defining a longitudinal axisand a handle connected to the body portion and obliquely arrangedrelative to the longitudinal axis, the distal end of the body portionbeing positioned farther from the handle than is the proximal end of thebody portion, the elongated body portion including at least two separatecooperating members, each cooperating member having internal surfacesdimensioned to define a longitudinal passage extending through theelongated body portion for reception of surgical instrumentation, thecooperating members operatively connected to each other and adapted forrelative movement between an approximated position wherein the internalsurfaces of the cooperating members engage the surgical instrumentationand a displaced position wherein the surgical instrumentation is movablerelative to the cooperating members, the handle including first andsecond movable members connected about a pin to define a scissors-gripconfiguration, the first and second movable members operativelyconnected to respective first and second cooperating members of the bodyportion to cause relative movement thereof between the approximated anddisplaced positions, and a locking mechanism operatively connected tothe first and second movable members of the handle, the lockingmechanism adapted to selectively lock the first and second movablemembers at desired relative positions to thereby secure the cooperatingmembers of the body portion at corresponding desired relative positionsbetween the approximated and displaced positions, the catheter having acatheter shaft defining proximal and distal ends, and being positionablewithin the longitudinal passageway of the body portion of the retractor,the catheter including an indicator lumen terminating in an indicatorport to permit passage of the body fluids to indicate entry withindesired tissue.
 13. The surgical apparatus according to claim 12 whereinthe body portion defines a distal tapered portion for facilitating entryinto tissue.
 14. The surgical apparatus according to claim 12 whereinthe catheter includes a stop region defining an enlarged cross-sectionaldimension relative to a region of the catheter shaft proximal of thestop region, the stop region dimensioned to engage the body portion toprevent advancement of the retractor within the tissue.
 15. The surgicalapparatus according to claim 14 wherein the catheter shaft includes anaperture in a side wall portion of the step region, the aperture beingthe indicator port.
 16. The surgical apparatus according to claim 14,wherein the catheter shaft further includes a guide lumen dimensionedfor reception of a guide element.
 17. The surgical apparatus accordingto claim 16 further including a guide element having a guide shaftdefining proximal and distal ends, and an inflatable member adjacent thedistal end thereof, the guide element positionable within the guidelumen to introduce the inflatable member into the target site.
 18. Amethod for facilitating closure of an opening in a blood vessel whereaccess to the opening is through a tissue passage extending throughtissue overlying the blood vessel, comprising the steps of: introducinga catheter within the tissue passage and at least partially within theblood vessel, the catheter having a catheter shaft defining proximal anddistal ends and an enlarged stop region adjacent the distal end;positioning a retractor about the catheter shaft of the catheter, theretractor including an elongated body having proximal and distal endsand defining a longitudinal axis and a handle connected to the elongatedbody and arranged in oblique relation to the longitudinal axis, theelongated body having first and second body portions defining alongitudinal passage therebetween and being adapted for selectiverelative movement between an approximated position and a displacedposition to accommodate an outer dimension of a wound closure device,the retractor being positioned such that the distal end of the elongatedbody is adjacent the stop region of the catheter; selectively moving atleast the first body portion of the retractor relative to the secondbody portion by manipulating the handle to a predetermined relativeposition to enlarge the tissue passage; removing the catheter from thetissue passage and the retractor; and inserting a wound closure devicethrough the first and second body portions of the retractor, andactuating the wound closure device to close the opening in the bloodvessel.
 19. The method according to claim 18 wherein the catheterincludes an inflatable member disposed adjacent the distal end of thecatheter shaft, and wherein the step of introducing includes positioningthe inflatable member through the opening and within the blood vesseland further including the step of expanding the inflatable member suchthat the inflatable member at least partially closes the opening in theblood vessel to minimize flow of blood through the opening.
 20. Themethod according to claim 18 wherein the step of positioning isperformed prior to the step of introducing.
 21. The method according toclaim 18 wherein the catheter includes an indicator lumen terminating inan indicator port in the stop region of the catheter shaft and whereinthe step of introducing includes advancing the catheter within thetissue passage whereby the indicator port is disposed within the bloodvessel as evidenced by the presence of blood within the indicator lumen.22. A surgical apparatus comprising a retractor and a catheter, theretractor including an elongated body portion having proximal and distalends and defining a longitudinal axis and a handle connected to the bodyportion and obliquely arranged relative to the longitudinal axis, thedistal end of the body portion being positioned farther from the handlethan is the proximal end of the body portion, the elongated body portionincluding at least two separate cooperating members, each cooperatingmember having internal surfaces dimensioned to define a longitudinalpassage extending through the elongated body portion for reception ofthe catheter, the cooperating members operatively connected to eachother and adapted for relative movement between an approximated positionwherein the internal surfaces of the cooperating members engage thecatheter and a displaced position wherein the catheter is movablerelative to the cooperating members, the handle including first andsecond movable members operatively connected to respective first andsecond cooperating members of the body portion to cause relativemovement thereof between the approximated and displaced positions, thecatheter having a catheter shaft defining proximal and distal ends, andbeing positionable within the longitudinal passageway of the bodyportion of the retractor, the catheter including an indicator lumenconfigured to permit viewing of body fluids passing through said lumenso as to indicate entry within desired tissue.
 23. The surgicalapparatus of claim 22, additionally comprising a locking mechanismoperatively connected to the first and second movable members of thehandle, the locking mechanism adapted to selectively lock the first andsecond movable members at desired relative positions to thereby securethe cooperating members of the body portion at corresponding desiredrelative positions between the approximated and displaced positions. 24.The surgical apparatus of claim 23, wherein the catheter has a holeformed through a side of the catheter near a distal end thereof, thehole communicating with the indicator lumen.
 25. The surgical apparatusof claim 23, wherein the catheter has a distal opening at a distal endof the catheter, and the distal opening is configured to slidinglyaccept a guidewire extending therethrough.
 26. A device to facilitatethe closure of wounds in the vasculature of a patient, comprising: abody portion having a retracting portion having two elongate movablemembers extending away from said body portion, said movable membersforming a channel through said retracting portion, each movable memberhaving a first end and a second end, the first end being positionedfarther from the body portion than the second end, the movable membersbeing movable between a retracted position and an approximated position;a handle portion connected to said body portion and configured tocontrol the movement of the two movable members, the handle having agrasp portion and a locking mechanism, the locking mechanism selectivelyengagable so as to prevent movement of the movable members from theretracted position toward the approximated position; and a catheteradapted to be positionable within the channel, the catheter having anopen distal end configured to slidingly receive a guidewiretherethrough, the catheter further comprising an indicator lumenconfigured so that a clinician can view fluids drawn through theindicator lumen.
 27. The device of claim 26, wherein the catheter has anarcuate outer surface, and the channel has a substantially complementarysurface sized and configured to engage the catheter outer surface.